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FDA 510(k)

faceLITE

K-Number: K191629 · 2019-09-12

ApplicantIsmart Marketing Svcs, Ltd.
Decision Date2019-09-12
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

faceLITE is the device name listed in this FDA 510(k) record. The listed applicant is Ismart Marketing Svcs, Ltd.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K191629. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the faceLITE?

faceLITE is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Ismart Marketing Svcs, Ltd.. The 510(k) number is K191629.

When did faceLITE receive FDA 510(k) clearance?

faceLITE received FDA 510(k) clearance on 2019-09-12, under 510(k) number K191629.

Who is the listed applicant for faceLITE?

The FDA 510(k) record lists Ismart Marketing Svcs, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for faceLITE?

The FDA product code for faceLITE is OHS.

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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